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| Sponsors and Collaborators: |
Children's Cancer Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005577 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of gemcitabine in treating children who have refractory solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: gemcitabine hydrochloride |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A PEDIATRIC PHASE I STUDY OF GEMCITABINE (NSC# 613327) IN SOLID TUMORS |
| Study Start Date: | August 1996 |
OBJECTIVES: I. Estimate the maximum tolerated dose of gemcitabine in children and adolescents with refractory solid tumors. II. Assess the toxicity of gemcitabine in this patient population. III. Determine the pharmacokinetic profile of gemcitabine in male and female children and adolescents. IV. Assess the antitumor activity of gemcitabine within a phase I study.
OUTLINE: This is a dose escalation study. Patients receive gemcitabine IV over 30 minutes weekly for 2 weeks. Patients achieving objective response or stable disease after 3 weeks may receive additional courses of therapy every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed at week 4 and then every 6 months until death.
PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study over 18 months.
Eligibility| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor Confirmation made at original diagnosis No bone marrow involvement Refractory to conventional therapy and other therapies of higher priority according to CCG Phase I/II Priority List
PATIENT CHARACTERISTICS: Age: 1 to 21 Performance status: 0-2 Life expectancy: At least 2 months Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 (transfusion independent) Hemoglobin at least 10 g/dL (transfusions allowed) Hepatic: Bilirubin no greater than 1.5 times normal AST less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or radioisotope GFR at least 70 mL/min Other: No seizure disorder Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic: At least 2 weeks since prior cytokine therapy and recovered No prior bone marrow transplantation Chemotherapy: No more than 3 prior combination or single agent chemotherapy regimens At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Contacts and Locations
Show 23 Study Locations| Study Chair: | John S. Holcenberg, MD | Seattle Children's Hospital |
More Information
| Study ID Numbers: | CDR0000064886, CCG-0954 |
| Study First Received: | May 2, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005577 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified childhood solid tumor, protocol specific |
|
Antimetabolites Radiation-Sensitizing Agents Immunologic Factors |
Gemcitabine Immunosuppressive Agents Antiviral Agents |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses Gemcitabine |
